Margene Manning, right, talks to research study coordinator Mary Beth Rodal in January during her participation on a clinical trial at University Hospitals Seidman Cancer Center. UH Seidman researchers are studying new technologies they hope will facilitate patient enrollment on clinical trials.Lynn Ischay, Plain Dealer

CLEVELAND, Ohio -- A lack of knowledge, preconceived attitudes and even fear are just a few of the barriers that make it difficult for oncologists to enroll cancer patients in clinical trials as a treatment option.

Other challenges are more logistical in nature -- regulatory requirements, staffing, etc. present hurdles for physicians as they try to match their patients with the best cancer clinical trial for them.

Positiveresults from two studies that used technology to make clinical trials for cancer patients more accessible and easier to understand will be presented today at the annual meeting of the American Society of Clinical Oncologists in Chicago.

Oncologists know that many patients are not prepared to have a discussion with their doctors about clinical trials, said Dr. Neal Meropol, chief of the division of hematology/oncology at University Hospitals Case Medical Center and Case Western Reserve University School of Medicine and associate director for clinical programs at UH Seidman Cancer Center.

"It makes it difficult for them to optimally weigh the pros and cons of clinical trials," he said.

"When you see patient in office, do you have time to find a clinical trial and talk about it [with the patient]?

"We're trying to cut down the time it takes."

To that end, Meropol led two studies that sought answers to those problems.

The first was a large-scale, randomized trial of a tool called PRE-ACT (Preparatory Education About Clinical Trials). The National Cancer Institute paid for the randomized study.

More than 1,200 patients took part at UH and the Cleveland Clinic (both are part of the Case Comprehensive Cancer Center), as well as at Fox Chase Cancer Center in Philadelphia; Karmanos Cancer Center in Detroit; and the Lurie Comprehensive Cancer Center of Northwestern University in Chicago.

Right after receiving a diagnosis, but before reviewing their treatment options with an oncologist, patients filled out an online survey that measured their knowledge of, and attitude toward, clinical trials.

Patients in the PRE-ACT group then watched three general online videos, then up to 10 more videos that were tailored to them based on their survey responses.Each web-based video (20 in all covering different topics) was between 30 and 90 seconds long. The videos, which took one year to produce, featured professional actors playing doctors, nurses and patients. Cancer advocacy and focus groups provided input on the scripts.

Patients in a second control group read information texts online, provided by the National Cancer Institute, that were not tailored to their individual barriers.

The results of the study, measured through a follow-up survey of both groups, showed that while PRE-ACT and the online text were effective in improving patient knowledge and reduced attitude-related barriers towards participation in clinical trials, patients in the PRE-ACT group said they felt more prepared to consider trials based on the information they received.

Because of the study results, researchers hope in the next few months to provide the videos on the hospitals' in-house television educational channels and explore how to make the videos available online.

The second study was a six-month pilot that usedtechnology that helps oncologists identify clinical trials for their patients.

"With the increase in information technology, we saw that as a window of opportunity to make a program that could improve cancer patient accruals," said Dr. Andrew Parchman, a hematology-oncology fellow at UH and co-author of the study.

Trial Prospector, an automated clinical trials eligibility matching program, was developed in 2012 by informatics specialists from CWRU and UH who worked with Case Comprehensive.

The program "reaches" into a patient's medical records and extracts 15 pieces of information, including a person's cancer diagnosis; age; and lab values from blood count and kidney and liver function tests. It then reviews the trials database (UH currently lists more than 300 cancer clinical trials at Seidman that are enrolling patients) and matches the patient to the eligibility criteria of a specific trial.

In a matter of minutes, Trial Prospector identifies any possible matches and generates a report for physicians without them having to enter data by hand.

"It's very challenging to memorize everything [about specific criteria of a clinical trial], Parchman said. "It streamlines the workflow and gets all the information for you."

The response from the 11 gastrointestinal oncologists at UH Case Medical Center who used Trial Prospector for 60 new patients, has been overwhelmingly positive, Parchman said.

Of the 60 patients, 11 percent were enrolled in a clinical trial, he said.

The percentage is pretty standard for an academic center, Parchman said. Researchers hope that with fine-tuning, the use of more patient information and a broader use across the UH system over the next year, the enrollment percentage will increase, he said.

The Clinical & Translational Science Collaborative of Cleveland and the National Institutes of Health paid for this study. Researchers hope to obtain more money to improve the program and expand Trial Prospector to other types of cancer. The tool potentially can be implemented at any institution with electronic medical records.

Clues to Cancer: Patients, doctors on road to discovery

For 10 months, Plain Dealer reporter Angela Townsend and photographer Lynn Ischay followed 9 patients through their journey as study participants in Phase 1 trials at University Hospitals. We tell their stories here.

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